NRx has refiled its Abbreviated New Drug Application for KETAFREE™ (preservative free ketamine), received supportive correspondence from FDA, and expects Q2 2026 GDUFA date.HOPE Therapeutics is now operating three revenue-generating facilities in Florida and expects six or more by year-end providing neuroplastic drugs, transcranial magnetic stimulation, hyperbaric therapy, and digital therapeutics to treat suicidal depression and PTSD.NRx has secured operating capital anticipated to be sufficient for drug d ...

Core Viewpoint - NRx Pharmaceuticals has re-filed its Abbreviated New Drug Application (ANDA) for KETAFREE™, a preservative-free IV ketamine formulation, following FDA approval of its Suitability Petition for the proposed strength of the drug [1][6]. Industry Overview - The current annual ketamine market is estimated at $750 million, with projections indicating growth to $3.35 billion globally by 2034 [2][6]. - An estimated 5.1 million Americans have received ketamine for medical uses, a number that continues to rise due to increased clinical focus [2]. Company Developments - NRx Pharmaceuticals aims to capture a significant share of the ketamine market and is seeking priority review from the FDA due to a severe drug shortage [2][4]. - The company has filed a citizen's petition to remove benzethonium chloride (BZT), a neurotoxic substance, from ketamine formulations intended for intravenous use [3][6]. - NRx's KETAFREE™ formulation is designed to eliminate toxic preservatives, aligning with current health priorities to remove harmful substances from drugs [6][7]. Manufacturing and Regulatory Context - The manufacturing of KETAFREE™ is in partnership with Nephron Pharmaceuticals, supporting the U.S. initiative to reshore critical drugs [4][6]. - The ANDA formulation is distinct from the New Drug Application (NDA) for NRX-100, which has received Fast Track Designation for treating suicidal ideation in depression [5][6]. Clinical Data and Future Prospects - NRx anticipates submitting clinical trial data from over 1,000 patients and real-world data from more than 180,000 patients, demonstrating the efficacy of ketamine compared to placebo and electroconvulsive therapy [5][6].

Core Viewpoint - NRx Pharmaceuticals has received FDA approval for a Suitability Petition for its preservative-free ketamine product, KETAFREE™, allowing for the re-filing of its Abbreviated New Drug Application, which aligns with U.S. policy objectives to re-shore important drugs and eliminate toxic preservatives [1][6]. Group 1: Product Development - The proposed KETAFREE™ product aims to replace the current multi-dose vials of ketamine that contain toxic preservatives, addressing safety concerns [1][6]. - NRx Pharmaceuticals is also developing NRX-100, a non-generic formulation of ketamine intended for treating suicidal depression and PTSD, under a separate New Drug Application [2][4]. Group 2: Market Potential - The current market for ketamine is estimated at $750 million, and the company believes KETAFREE™ will be a successful addition to this market [2]. Group 3: Regulatory Engagement - NRx Pharmaceuticals was selected to attend a listening session hosted by the FDA Commissioner for biotechnology CEOs, indicating strong engagement with regulatory authorities [3]. - The rapid response from the FDA regarding the Suitability Petition is seen as a positive sign for the company's future product launch [3]. Group 4: Company Overview - NRx Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapeutics for central nervous system disorders, including suicidal depression and PTSD [4]. - The company has received Fast Track Designation for NRX-100 and Breakthrough Therapy Designation for NRX-101, highlighting its commitment to addressing critical mental health issues [4].